2017

Current Good Manufacturing Practices for Food

Title 21 Code of Federal Regulations (CFR) Part 117, Subpart B

Presented By:

California Department of Public Health Food and Drug Branch

Phone (916) 650-6500 Email FDBTraining@cdph.ca.gov

Presentation Goals

Key Terms

Four Major Components

Questions

Key Terms

Must* mandatory. Replaced shall,which was defined

Adequate what is needed to accomplish the intended

purpose in keeping with good public health practice

Should and all advisory languageremoved

Suitable* adapted to a use or purpose; proper; able; qualified * Dictionary

Definitions

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mailto:FDBTraining@cdph.ca.gov

2017

GOOD MANUFACTURING PRACTICES

Sanitary Controls and Conditions

Processing Controls ADEQUATE

SUITABLE

GMP Triple Threat Food

Food Contact Surfaces

Food Packaging and Materials

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Buildings, fixtures, and physical facilities must be maintained in a sanitary condition and in repair adequate to prevent contamination 21 CFR 117.35(a)

Grounds The grounds under control of the operator must be maintained in a manner to protect against the contamination of food.

21 CFR 117.20(a)(1-4)

Storing equipment Litter and waste

Weeds and grass Roads and yards

Drainage Waste systems

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Grounds The grounds not under control of the operator and not adequately maintained: care shall be exercised to prevent food contamination through:

117.20(a)(5)

Inspection Extermination Other means

Facilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations

117.20(b)(1), (2)

Space for equipment and storage Food safety + allergen controls Operating practices Effective design Other effective means

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What do you see?

Bad News

- pest droppings

Good News

- visual inspection

Your facility design must allow for product protection via either:

Partition Space Time

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Facilities

Plant buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(5)

Adequate lighting

Safety fixtures

Facilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations

117.20(b)(3)

Outdoor Bulk Vessels Construction

- adequately cleaned - adequate space - good repair 117.35(a)

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Facilities Buildings and structures must be of suitable size construction and design to facilitate maintenance and sanitary operations

117.20(b)(4)

Construction - drip and condensate

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Facilities

Buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations.

117.20(b)(6)

Adequate ventilation

Sanitary Facilities 117.37(b), (c), (f)

Each plant must be equipped with adequate sanitary facilities: -Plumbing

-Properly sized -Avoid being a source of contamination -Floor Drainage -No Back flow or Cross connections

- Sewage Disposal - Rubbish and offal disposal

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Water Supply 117.37(a) Adequate Source Safe and Sanitary Quality Suitable Temperature Appropriate Pressure

117.80(b)(1) Water used for washing, rinsing, or conveying food must be of safe and sanitary quality Water, if reused cannot increase the level of contamination in food

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Sanitary Facilities 117.37(d)

Toilet Facilities - Adequate, readily accessible - Must be kept clean - Must not be a potential source of contamination

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Sanitary Facilities 117.37(e)

Handwashing Facilities To ensure hands are not a source of

contamination

Adequate (soap, towels) Convenient Running water at suitable temperature

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Facilities and Grounds

Sanitary Facilities (110.37 e)Handwashing Facilities

- Cleaning and Sanitizing Agents

- Sanitary Towel or hand drying devices

- Signs- Refuse containers

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Pest Control 117.20(b)(7)

Provide adequate screening or other protection against pests.

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Pest Control 117.35(c)

No pests allowed in plant Take effective measures to exclude from processing areas Pesticide use permitted only under precautions + restrictions

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Why are good personnel practices

necessary?

Personnel 117.10(a) Management must take reasonable measures

to ensure:

Disease control - Medical Exam - Observation - Exclusion - Reporting

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Personnel 117.10(b) Management must take reasonable measures

to ensure:

Cleanliness through hygienic practices

Outer garments

Personal cleanliness

Washing hands thoroughly

Personnel 117.10(b) Management must take reasonable measures

to ensure:

Cleanliness through hygienic practices Jewelry Clothing storage areas

Gloves Confine eating, drinking, smoking Hair restraints Allergen cross-contact

Foreign substances

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Personnel Management must take reasonable measures

to ensure:

Education and Training 117.4(b) and (d), and 117.9

Proper Supervision 117.4(b) and (c)

Im the boss here!

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Equipment Must be designed and of such material, and workmanship to be adequately cleanable and maintained. 117.40 Avoid adulteration with:

- lubricants - fuel - metal fragments - contaminated water

Facilitate cleaning and maintenance

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Equipment 117.40(a), (b)

Designed to withstand food, cleaning and sanitizing

Smoothly bonded seams

Taken apart for thorough cleaning 117.80(c)(1)

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Equipment 117.40(a)

Must be: Installed and maintained to facilitate cleaning Corrosion resistant Non-toxic

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Equipment

Non-food contact surfaces

Constructed to be kept clean 117.40(c)

Cleaned as necessary to protect against allergen cross-contact and contamination 117.35(e)

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Equipment 117.40(e)

Accurate temperature measuring or recording devices required for freezers and cold storage units

Equipment 117.40(f) and (g) Instruments and controls for measuring conditions that prevent the growth of microorganisms must be:

- accurate and precise - maintained - adequate in number

Compressed air must not be a source of contamination

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Sanitary Operations 117.35(a)

Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and contamination

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Sanitary Operations 117.35(b)(1)

Cleaning and sanitizing agents must be: - Free from microorganisms - Safe - Adequate

Must be Verified by either: Letter of Guarantee, Certification, or, Examination

Sanitary Operations 117.35(b)

Use or store toxic agents only for:

- Cleaning and sanitizing - Laboratory - Maintenance and operations

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Sanitary Controls 117.35(b)(2)

Toxic Agents must be: Identified: Labels! Held and stored to protect

against contamination

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Sanitation of Food Contact Surfaces 117.35(d)

Must be cleaned as frequently as necessary to protect from allergen cross-contact and contamination.

Wet Sanitation Dry Sanitation

Sanitation of Food Contact Surfaces 117.35

Single service articles 117.35(d)

Sanitizing agents 117.35(e)

Portable equipment 117.35(f)

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Processes and Controls 117.80

All operations must be conducted in accordance with adequate sanitation principles

Appropriate quality control operations must be employed

Adequate precautions must be taken to protect from allergen cross-contact and contamination

Processes and Controls 117.80(b)(2)

Ingredients must not contain levels of microorganisms that may be injurious to health,

or

Ingredients must be pasteurized or otherwise treated.

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Receiving

Holding

Manufacturing

Distribution

Packaging/Labeling

Storage

Raw Materials

Manufacturing Operations

Raw Materials 117.80(b)(1)

Must be: Inspected, segregated or handled as

necessary, to determine they are clean and suitable

Stored while protecting from allergen cross-contact and contamination, and minimizing deterioration

Washed and cleaned, as necessary, to remove contaminants

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Acceptable food storage practice?

Raw Materials 117.80(b)(1)

Raw Materials and Ingredients must be inspected to ensure they are clean and suitable, and stored in a way to prevent allergen cross-contact, contamination, and deterioration.

Raw Materials 117.80(b)(3)

Susceptible to aflatoxin or other natural toxins must comply with FDA regulations, guidelines, and action levels.

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Raw Materials 117.80(b)(4), 117.110

Susceptible to pests or other undesirable microorganisms or extraneous materials shall comply with FDA defect action levels.

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Raw Materials 117.80(b)(5), (b)(7)

Held in bulk containers must be held while protecting from allergen cross-contact, contamination, and adulteration

Materials scheduled for re-work must be identified as such

Raw Materials 117.80(b)(6)

Frozen ingredients must be kept frozen. If thawed, it must be done in a manner that prevents adulteration.

Manufacturing Operations 117.80(c)(2)

Comply by monitoring: Physical Factors Manufacturing Time Freezing Flow Rate Dehydration Aw Heat Processing pH Acidification Temperature Refrigeration Pressure Irradiation Humidity

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Manufacturing Operations 117.80(c)(2)

All food manufacturing, including packaging and storage, must be conducted under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination, and deterioration.

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Manufacturing Operations 117.80(c)(3)

FOODS THAT CAN SUPPORT THE RAPID GROWTH OF UNDESIRABLE MICROORGANISMS MUST BE HELD AND PROCESSED IN A MANNER THAT PREVENTS THE FOOD FROM BECOMING ADULTERATED

Manufacturing Operations H&SC 110980, 21 CFR 117.80(c)(3)

Refrigerated foods at < 45oF Frozen foods in frozen state Heat treating or acidifying foods held

at ambient temperatures in hermetically sealed containers

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Exercise

Additional Considerations Hazard Analysis and Risk Based Preventive

Controls

Food Allergen/Sanitation/Supply-Chain Controls

Recall Plan

Environmental Monitoring Program

Reportable Food Registry

FDA Bioterrorism Registration

Validation of Processes

Audit Programs (ISO/BRC/ETC)

Contacts State Government

CDPH-Food and Drug Branch P.O. Box 997435; MS 7602 Sacramento, CA 95899-7435 E-mail: FDBtraining@cdph.ca.gov (916) 650-6500

California Department of Food and Agriculture 1220 N Street Sacramento, California, U.S.A. 95814 www.cdfa.ca.gov (916) 654-0466

Federal Government

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov 1-888-INFO-FDA (1-888-463-6332)

U.S. Department of Food and Agriculture 620 Central Avenue, Building 2C Alameda, CA 94501 www.fsis.usda.gov (510) 337-5000 (Alameda District)

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http:www.fsis.usda.govhttp:www.fda.govhttp:www.cdfa.ca.govmailto:FDBtraining@cdph.ca.govwww.cdfa.ca.govwww.fda.govwww.fsis.usda.gov

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Structure BookmarksCurrent Good Manufacturing Practices for Food FigureTitle 21 Code of Federal Regulations (CFR) Part 117, Subpart B Title 21 Code of Federal Regulations (CFR) Part 117, Subpart B

Presented By: California Department of Public Health Food and Drug Branch Phone (916) 650-6500 Email FDBTraining@cdph.ca.gov

Presentation Goals Presentation Goals Key Terms Four Major Components Questions Must* mandatory. Key Replaced shall,Terms which was defined Should and which was defined Should and which was defined Should and Adequate what is needed to

all advisory

accomplish the intended languagepurpose in keeping with good removed public health practice Suitable* adapted to a use or * Dictionary purpose; proper; able; qualified Definitions * Dictionary purpose; proper; able; qualified Definitions

OOD MANUFACTURING PRACTICES G

Sanitary Controls and Conditions Processing Controls ADEQUATE SUITABLE GMP Triple Threat Food Food Contact Surfaces Food Packaging and Materials FigureBuildings, fixtures, and physical facilities must be maintained in a sanitary condition and in repair adequate to prevent contamination 21 CFR 117.35(a) FigureGrounds The grounds of the operator must be maintained in a manner to protect against the contamination of food. under control

21 CFR 117.20(a)(1-4) Storing equipment Litter and waste Weeds and grass Roads and yards Drainage Waste systems 2017 Grounds The grounds of the operator and : care shall be exercised to prevent food contamination through: not under control not adequately maintained

117.20(a)(5) Inspection Extermination Other means FigureFacilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations 117.20(b)(1), (2) Space for equipment and storage

Food safety + allergen controls

Operating practices

Effective design

Other effective means

FigureFigureFigureWhat do you see? Bad News -pest droppings Good News -visual inspection Partition Space Time Your facility design must allow for product protection via either: Facilities Plant buildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(5) Adequate lighting

Safety fixtures

FigureFacilities Buildings and structures must be of suitable size, construction, and design to facilitate maintenance and sanitary operations 117.20(b)(3) Outdoor Bulk Vessels Construction -adequately cleaned -adequate space 117.35(a) -good repair

Facilities Buildings and structures must be of suitable size construction and design to facilitate maintenance and sanitary operations 117.20(b)(4) Construction -drip and condensate -drip and condensate Facilities

FigureFigureFigureBuildings and structures must be suitable in size, construction and design to facilitate maintenance and sanitary operations. 117.20(b)(6) Adequate ventilation Sanitary Facilities 117.37(b), (c), (f) Each plant must be equipped with adequate sanitary facilities: -Plumbing -Properly sized -Avoid being a source of contamination -Floor Drainage -No Back flow or Cross connections -Sewage Disposal -Rubbish and offal disposal 2017 FigureFigureWater Supply Water Supply 117.37(a) AdequateAdequateAdequate Source

SafeSafe and Sanitary Quality

SuitableSuitable Temperature

AppropriateAppropriate Pressure

117.80(b)(1) WaterWaterWater used for washing, rinsing, or conveying food must be of safe and sanitary quality

Water, Water, if reused cannot increase the level of contamination in food

FigureFigureFigure117.37(d) Sanitary Facilities

Toilet Facilities -Adequate, readily accessible -Must be kept clean -Must not be a potential source of contamination -Adequate, readily accessible -Must be kept clean -Must not be a potential source of contamination Sanitary Facilities 117.37(e)

FigureFigureFigureHandwashing Facilities

To ensure hands are not a source of contamination

Adequate (soap, towels)

Convenient

Running water at suitable temperature

FigureFigure117.20(b)(7) Pest Control

Provide adequate screening or other protection against pests. FigureFigure117.35(c) Pest Control

No pests allowed in plant

Take effective measures to exclude from processing areas

Pesticide use permitted only under precautions + restrictions

FigureFigureWhy are good personnel practices necessary? 117.10(a) Personnel

Management must take reasonable measures to ensure: Disease control -Medical Exam -Observation -Exclusion -Reporting 117.10(b) Personnel

Management must take reasonable measures to ensure: Cleanliness through hygienic practices OuterOuterOuter garments

PersonalPersonal cleanliness

WashingWashing hands thoroughly

Figure117.10(b) Personnel

Management must take reasonable measures to ensure: Cleanliness through hygienic practices Jewelry Jewelry Jewelry Clothing storage areas

Gloves Gloves Confine eating, drinking,

Hair restraints Hair restraints smoking

TRAllergen cross-contact

TRForeign substances

FigureFigureFigureFigurePersonnel Management must take reasonable measures to ensure:

Education and Training Education and Training 117.4(b) and (d), and 117.9

Proper Supervision Proper Supervision 117.4(b) and (c) Im the boss here! FigureEquipment Must be designed and of such material, and workmanship to be adequately cleanable and maintained. 117.40 Avoid adulteration with: -lubricants -fuel -metal fragments -contaminated water

Facilitate cleaning and maintenance

FigureEquipment 117.40(a), (b) Designed to withstand food, cleaning and sanitizing

Smoothly bonded seams

Taken apart for thorough cleaning 117.80(c)(1)

FigureFigureFigureEquipment 117.40(a) Must be: Installed and maintained to facilitate cleaning

Corrosion resistant

Non-toxic

FigureEquipment Non-food contact surfaces Constructed to be kept clean 117.40(c) Cleaned as necessary to protect against allergen cross-contact and contamination 117.35(e) FigureFigure117.40(e) Equipment

Accurate temperature measuring or recording devices required for freezers and cold storage units Figure117.40(f) and (g) Equipment

Instruments and controls for measuring conditions that prevent the growth of microorganisms must be: -accurate and precise -maintained -adequate in number Compressed air must not be a source of contamination Figure117.35(a) Sanitary Operations

Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and contamination FigureFigure117.35(b)(1) Sanitary Operations

Cleaning and sanitizing agents must be: -Free from microorganisms -Safe -Adequate Must be Verified by either: Letter of Guarantee,

Certification, or,

Examination

117.35(b) Sanitary Operations

Use or store toxic agents only for: -Cleaning and sanitizing -Laboratory -Maintenance and operations Figure117.35(b)(2) Sanitary Controls

Toxic Agents must be: Identified: Labels!

Held and stored to protect against contamination

FigureFigureSanitation of Food Contact Surfaces 117.35(d) Must be cleaned as frequently as necessary to protect from allergen cross-contact and contamination. Wet Sanitation

Dry Sanitation

Sanitation of Food Contact Surfaces 117.35 Single service articles Single service articles Single service articles 117.35(d)

Sanitizing agents Sanitizing agents 117.35(e)

Portable equipment Portable equipment 117.35(f)

FigureProcesses and Controls 117.80 operations must be conducted in accordance with adequate sanitation principles All

quality control operations must be employed Appropriate

precautions must be taken to protect from allergen cross-contact and contamination Adequate

Processes and Controls 117.80(b)(2) Ingredients must not contain levels of microorganisms that may be injurious to health, or Ingredients must be pasteurized or otherwise treated. Receiving Holding Manufacturing Distribution Packaging/Labeling Storage Raw Materials

Manufacturing Operations Manufacturing Operations Raw Materials 117.80(b)(1) Must be: Inspected, segregated or handled as necessary, to determine they are clean and suitable Stored while protecting from allergen cross-contact and contamination, and minimizing deterioration Washed and cleaned, as necessary, to remove contaminants Acceptable food storage practice? Raw Materials 117.80(b)(1) Raw Materials and Ingredients must be inspected to ensure they are clean and suitable, and stored in a way to prevent allergen cross-contact, contamination, and deterioration. Raw Materials 117.80(b)(3) Susceptible to aflatoxin or other natural toxins must comply with FDA regulations, guidelines, and action levels. Figure

Raw Materials Raw Materials 117.80(b)(4), 117.110 Susceptible to pests or other undesirable microorganisms or extraneous materials shall comply with FDA defect action levels. Figure

Raw Materials Raw Materials 117.80(b)(5), (b)(7) Held in bulk containers must be held while protecting from allergen cross-contact, contamination, and adulteration

Materials scheduled for re-work must be identified as such

Raw Materials Raw Materials 117.80(b)(6) Frozen ingredients must be kept frozen. If thawed, it must be done in a manner that prevents adulteration. Manufacturing Operations 117.80(c)(2) Comply by monitoring: Physical Factors Manufacturing Physical Factors Manufacturing

Time Freezing Flow Rate Dehydration Aw Heat Processing pH Acidification Temperature Refrigeration Pressure Irradiation Humidity

Manufacturing Operations Manufacturing Operations 117.80(c)(2) All food manufacturing, including packaging and storage, must be conducted under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination, and deterioration. FigureFigure

Manufacturing Operations Manufacturing Operations 117.80(c)(3) FOODS THAT CAN SUPPORT THE RAPID GROWTH OF UNDESIRABLE MICROORGANISMS MUST BE HELD AND PROCESSED IN A MANNER THAT PREVENTS THE FOOD FROM BECOMING ADULTERATED

Manufacturing Operations Manufacturing Operations H&SC 110980, 21 CFR 117.80(c)(3) Refrigerated foods at 45F < o

Frozen foods in frozen state

Heat treating or acidifying foods held at ambient temperatures in hermetically sealed containers

FigureExercise Additional Considerations Hazard Analysis and Risk Based Preventive Controls

Food Allergen/Sanitation/Supply-Chain Controls

Recall Plan

Environmental Monitoring Program

Reportable Food Registry

FDA Bioterrorism Registration

Validation of Processes

Audit Programs (ISO/BRC/ETC)

Contacts Contacts State Government State Government

CDPH-Food and Drug Branch P.O. Box 997435; MS 7602 Sacramento, CA 95899-7435 E-mail: (916) 650-6500 FDBtraining@cdph.ca.gov FDBtraining@cdph.ca.gov

California Department of Food and Agriculture 1220 N Street Sacramento, California, U.S.A. 95814 www.cdfa.ca.gov www.cdfa.ca.gov www.cdfa.ca.gov

(916) 654-0466 Federal Government Federal Government

U.S.Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov www.fda.gov www.fda.gov

1-888-INFO-FDA (1-888-463-6332) U.S. Department of Food and Agriculture 620 Central Avenue, Building 2C Alameda, CA 94501 www.fsis.usda.gov www.fsis.usda.gov www.fsis.usda.gov

(510) 337-5000 (Alameda District) Figure2017 Figure